GSK's Revolade cleared for use in hepatitis C therapy

Adds to drug’s existing thrombocytopenia indication

GlaxoSmithKline (GSK) has secured EU approval for its platelet-boosting drug Revolade in patients with hepatitis C virus (HCV), setting up a potential leap forward in sales.

The European Medicines Agency (EMA) has given a green light for Revolade (eltrombopag) to treat adult HCV patients in whom thrombocytopenia is interfering with the use of interferon alfa-based therapies.

Treatment with interferon can sometimes reduce platelet levels, and patients with this complication can be excluded from starting or being maintained on treatment, leading to quicker progression of the illness.

Revolade was first launched in 2010 as a treatment for the blood disorder chronic immune (idiopathic) thrombocytopenia (ITP), a relatively rare condition, and, while sales to date have been fairly modest, analysts have suggested use in HCV could provide an uptick.

In 2011 Revolade made £75m (around $115m), rising to £130m last year thanks in no small part to approval of the HCV indication in the US, where the drug is sold as Promacta. The product has continued to gain momentum in 2013 with first-half sales rising more than 50 per cent to £85m.

GSK pays single-digit royalties on sales of the drug to Ligand Pharmaceuticals of the US, whose chief executive John Higgins, said recently that 2013 sales are expected to reach around $300m.

It has been suggested that sales of the drug could move into blockbuster territory thanks to the HCV indication, as there are so many people around the world (some 180 million) who are chronically infected with the virus.

The prospects for the drug in HCV are somewhat clouded by the promise of all-oral antiviral regimens for the hepatitis C which could materially impact the size of the interferon alfa market, although Higgins believes there will still be a role for Revolade/Promacta.

"We fully understand the landscape will change [and] there will be less use of interferon," he said during the firm's second-quarter results call.

"Our view is that the sickest patients … will still have low platelet count and may benefit by using Promacta," he continued, adding that generic interferon alfa products will soon emerge that will continue to be a staple of treatment in emerging economies where the new oral drugs may be unaffordable.

Meanwhile, GSK is also running dozens of other trials of the drug in additional indications, including aplastic anaemia, myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML), which could provide additional upside to sales.

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